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Study Title and Description

Er:YAG ablative fractional laser-primed photodynamic therapy with methyl aminolevulinate as an alternative treatment option for patients with thin nodular basal cell carcinoma: 12-month follow-up results of a randomized, prospective, comparative trial.



Key Questions Addressed
1 Comparison of interventions
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Primary Publication Information
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TitleData
Title Er:YAG ablative fractional laser-primed photodynamic therapy with methyl aminolevulinate as an alternative treatment option for patients with thin nodular basal cell carcinoma: 12-month follow-up results of a randomized, prospective, comparative trial.
Author Choi SH., Kim KH., Song KH.
Country Department of Dermatology, College of Medicine, Dong-A University, Seo-gu, Busan, South Korea.
Year 2016
Numbers Pubmed ID: 26551044

Secondary Publication Information
There are currently no secondary publications defined for this study.


Extraction Form: Comparative studies
Arms
Number Title Description Comments
1 Er:YAG ablative fractional laser-primed MAL- PDT
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2 MAL-PDT
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Design Details
Question... Follow Up Answer Follow-up Answer
Publication or abstract? Publication
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Study design RCT
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Multicenter etc. Single center
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Country/Region korea
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Funding No industry support
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Inclusion criteria We enrolled ≥18-year-old patients who had previ- ously untreated thin primary nBCC, provided that they satisfied both of the following conditions: (i) a maximum tumour depth of 2 mm in a biopsy specimen and clinical evaluation, and (ii) surgical excision would be difficult because of bleeding abnor- malities or cardiac problems.
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Exclusion criteria more than five eligible lesions; lesions located in the midface region, nose, orbital areas or ears; lesions with a longest diameter more than 15 mm; histologic subtype other than nodular; known allergies to the methyl aminolevulinate cream or lidocaine; pregnancy or lactation; any active systemic infectious disease; immunosuppressive treatment; personal history of malignant melanoma; tendency toward melasma or keloid for- mation; and any indication of poor compliance.
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N Enrolled/Randomized/Analyzed 39 (42 lesions)
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39 (42 lesions)
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34 patients (37 lesions)
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Notes/Comments per protocol numbers used for "N analyzed" (5 lost to follow up, i checked with gaelen, and this is what we decided to do )
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Method of diagnosis ... Describe Biopsy/pathologic confirmation ...
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Percent non-primary (recurrent) 0%
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Secondary size assessment
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Baseline Characteristics
Question Er:YAG ablative fractional laser-primed MAL- PDT MAL-PDT Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Continuous baselines 66.9 63.3
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9.6 10.7
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19 18
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Gender/Racial descent 11 7
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55 36.8
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Lesion location No data entered.
Skin type (Fitzpatrick score) 3 2
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15 10.5
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13 14
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65 74.7
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4 3
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20 15.8
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Number of lesions per patient No data entered.
Previous treatments No data entered.
Immunocompromized status No data entered.
Number of patients/lesions 20 19
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21 21
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20 19
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21 21
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2 3
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2 3
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1 lost to follow up and 1 protocol violation. 2 lost to follow up, 1 health problem
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18 16
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19 18
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Lesion extent number of people 20 patients (21 lesions) 19 patients (21 lesions)
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Lesion extent number of people No data entered.



Results & Comparisons


Results Data
Outcome: Lack of clinical clearance      Population: All Participants
Time Point Measure Er:YAG ablative fractional laser-primed MAL- PDT MAL-PDT


3 months

N Analyzed 21 lesions 21 lesions
Counts 5 lesion 12 lesions


12 months

N Analyzed 21 lesion 21 lesions
Counts 6 lesions 17 lesions.
Outcome: Cosmetic outcome (categorical)      Population: All Participants
Time Point Measure Er:YAG ablative fractional laser-primed MAL- PDT MAL-PDT


12 months

N Analyzed 18 16
Counts 11 11
Outcome: Cosmetic outcome (categorical)      Population: All Participants
Time Point Measure Er:YAG ablative fractional laser-primed MAL- PDT MAL-PDT


12 months

N Analyzed 18 16
Counts 17 16
Outcome: Adverse events: Any      Population: All Participants
Time Point Measure Er:YAG ablative fractional laser-primed MAL- PDT MAL-PDT


n/a N/A

N Analyzed 18 16
Counts 18 16
Outcome: Adverse events: Any serious/severe      Population: All Participants
Time Point Measure Er:YAG ablative fractional laser-primed MAL- PDT MAL-PDT


throughout study period N/A

N Analyzed 18 16
Counts 0 0
Outcome: Adverse events: pain      Population: All Participants
Time Point Measure Er:YAG ablative fractional laser-primed MAL- PDT MAL-PDT


During illumination N/A

N Analyzed 20 patients (21 lesions) 19 patients (21 lesions)
Mean 4.632 4.222
SD 1.257 1.865
SE


Quality Dimensions
Dimension Value Notes Comments
RCT:....Adequate generation of a randomized sequence reported Unsure did not elaborate on how subjects were randomized
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RCT:....Adequate allocation concealment reported Yes
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RCT:....Adequate blinding of PATIENTS reported Yes
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RCT:....Adequate blinding of PROVIDERS reported Yes
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ALL....Adequate blinding of OUTCOME ASSESSORS reported Yes
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ALL.....Incomplete results data: are more than 20% missing for any eligible outcome in any group? No
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ALL.....Selective Reporting (judgement - put directly into notes field). No
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RCT.....Is the treatment effect by Intention to treat? No five subjects dropped out prematurely for unrelated reasons to study and were analyzed as treatment failures. discussed with gaelen who did not think it effected outcomes or data based on bounding analysis.
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ALL....Group similarity at baseline. Yes
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ALL....Additional Bias: Bias due to problems not covered elsewhere. (judgement - put directly into notes field) No
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ALL (with AE results)....Were reported adverse events (of interest) precisely defined Yes
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Overall, by outcome (judgement - put directly into notes field) low for all outcomes
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ALL.....Incomplete results data: Is there differential missingness (more than 20%) between arms for any eligible outcome? No
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Quality Rating
Guideline Used Overall Rating